Warmer than expected CPI data for August seemed to guarantee a 25 pbs rate cut for the September FOMC meeting, but markets have since priced in a >50% chance of a jumbo 50 bps cut. Macro considerations will likely take the lead for the remainder of the week while investors consider positioning post the initiation of rate cuts.
Despite elevated levels of political theater, specific health policies have been generally absent from either candidates' talking points suggesting major near term policy changes are unlikely.
M&A:
Silk Road Medical (SILK) announced expiration of HSR Act waiting period for acquisition by Boston Scientific (BSX).
Regulatory:
Zentalis Pharmaceuticals (ZNTL) announced FDA has lifted the clinical hold on Azenosertib.
FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) voted 13 to 1 that there is unfavorable risk/benefit with Alfasigma’s (private) Ocaliva (acquired from purchase of Intercept Pharmaceuticals) in primary biliary cholangitis (PBC). FDA is expected to potentially restrict use or remove the drug from the market in the coming weeks.
The US House of Representatives passed legislation last Monday night that would blacklist Chinese biotech companies and their US subsidiaries. The bill, approved by a vote of 306 to 81, now goes to the Senate.
Clinical:
Exact Sciences (EXAS) presented data demonstrating advancement in blood-based colorectal cancer screening at ESMO 2024 showing CRC sensitivity of 88% and specificity of 90%. These results were well received, coming in higher than CMS minimums for reimbursement, which are CRC sensitivity of 74% and specificity of 90%. Full data from the pivotal BLUE-C trial is expected in 1H 2025.
Ascendis Pharmaceuticals (ASND) announced TransCon CNP showed AGV of 1.49 cm/yr vs placebo in the pivotal trial in achondroplasia patients. The weekly injection compares to BioMarin's (BMRN) approved daily injectable Voxzogo that showed a 1.57 cm/year AGV difference in the pivotal trial.
Gilead Sciences (GILD) reported twice yearly HIV prevention therapy lencapavir reduced HIV infections by 96% in a 2,180 patient preventative study.
Iteos Therapeutics (ITOS) fell ~25% after partner GSK reported the TIGIT and PD1 combo produced a 59% response rate, but three patients died from immune related complications raising toxicity concerns.
Fulcrum Therapeutics (FULC) fell >60% on releasing results from the Phase 3 REACH trial of MAPK inhibitor losmapimod on Facioscapulohumeral Muscular Dystrophy (FSHD) that failed to meet the primary endpoint. FULC will discontinue development of losmapimod in FSHD.
Viridian Therapeutics (VRDN) announced positive data from the THRIVE Ph 3 trial for veligrotug that appeard in line with market leader AMGN's Tepezza.
Capital Markets:
Three biotech IPOs priced last week raising >$770 million showing renewed signs of life in the sector.
Corporate Updates and Earnings:
Coherus Biosciences (CHRS) announced a temporary supply interruption for Udenyca due to delays in labeling and packaging at a third-party contract manufacturing organization. CHRS expects to resume manufacturing in mid-October and plans to offset near term revenue impact with sales later in 4Q.
Culling the Herd:
Moderna (MRNA) announced a 20% cut to R&D spending bringing down the 2025-2028 projected spend to $16 billion from $20 billion. MRNA estimates cash flow breakeven may be now achieved in 2028 from the earlier stated goal of 2026.
Cidara Therapeutics (CDTX) announced a 30% workforce reduction to focus all resources on flu prevention program CD388.
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